The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Recap Ha Press-fit Femoral Resurfacing Head.
| Device ID | K071053 |
| 510k Number | K071053 |
| Device Name: | RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD |
| Classification | Prosthesis, Hip, Femoral, Resurfacing |
| Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Becky Earl |
| Correspondent | Becky Earl BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KXA |
| CFR Regulation Number | 888.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-13 |
| Decision Date | 2007-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304684645 | K071053 | 000 |
| 00880304684447 | K071053 | 000 |
| 00880304684461 | K071053 | 000 |
| 00880304684485 | K071053 | 000 |
| 00880304684508 | K071053 | 000 |
| 00880304684522 | K071053 | 000 |
| 00880304684546 | K071053 | 000 |
| 00880304684560 | K071053 | 000 |
| 00880304684584 | K071053 | 000 |
| 00880304684607 | K071053 | 000 |
| 00880304684621 | K071053 | 000 |
| 00880304684423 | K071053 | 000 |